Search Results - "Food and Drug Administration"

United States Food and Drug Administration's authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America by Robert Eckford, Gianella Severini, Ernesto M. Sebrié, Monique E. Muggli, Alexandra Beem, Debra Rosen, Eric Crosbie

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Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023 by Dana E. Moseson, Trong Bien Tran, Bharathi Karunakaran, Rohan Ambardekar, Tze Ning Hiew

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Do drug package inserts meet the rules and regulations of Iran's Food and Drug Administration in terms of informing patients? by Tahereh Eteraf-Oskouei, Saeid Abdollahpour, Moslem Najafi, Vahideh Zarea Gavgani

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Increased Confidence in Deduplication of Drug Safety Reports with Natural Language Processing of Narratives at the US Food and Drug Administration by Kory Kreimeyer, Oanh Dang, Jonathan Spiker, Paula Gish, Jessica Weintraub, Eileen Wu, Robert Ball, Taxiarchis Botsis

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Regulatory landscape analysis of Myanmar Food and Drug Administration based on the World Health Organization Global benchmarking tool by Ei Ei Chaw, Ei Ei Chaw, Leena Suntornsuk

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Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system by Yan Liu, Hailong Li, Liang Huang, Chaomin Wan, Huiqing Wang, Xuefeng Jiao, Linan Zeng, Zhijun Jia, Guo Cheng, Lei Zhang, Wei Zhang, Lingli Zhang

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The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review by Sanjana Mukherjee

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Bridging the Health Equity Gap: An Update from the U.S. Food and Drug Administration Office of Minority Health and Health Equity by Richardae Araojo, Christine Lee, Milena Lolic

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The association between proton pump inhibitors and myocardial infarction: What do food and drug administration data tell us? by Jiun Ming Tan, Richard Parsons, Tin Fei Sim, Ya Ping Lee

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The United States Food and Drug Administration (FDA) regulatory response to combat neglected tropical diseases (NTDs): A review. by Sanjana Mukherjee

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Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System by Zahid Ali, Mohammad Ismail, Inayat Ur Rehman, Khang Wen Goh, Pakhrur Razi, Long Chiau Ming

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Is There a Risk for Semaglutide Misuse? Focus on the Food and Drug Administration's FDA Adverse Events Reporting System (FAERS) Pharmacovigilance Dataset by Stefania Chiappini, Rachel Vickers-Smith, Daniel Harris, G. Duccio Papanti Pelletier, John Martin Corkery, Amira Guirguis, Giovanni Martinotti, Stefano L. Sensi, Fabrizio Schifano

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Medication-induced osteonecrosis of the jaw: a review of cases from the Food and Drug Administration Adverse Event Reporting System (FAERS) by Hardeep S. Ahdi, Thomas Adam Wichelmann, Sasirekha Pandravada, Eli D. Ehrenpreis

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Comparison of the safety profiles for pirfenidone and nintedanib: a disproportionality analysis of the US food and drug administration adverse event reporting system by Xiangyu Sun, Xiangyu Sun, Huaguang Wang, Xi Zhan, Yuanyuan Yan, Kun Chen, Zhuoling An, Hong Zhou

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Safety profiles of methylphenidate, amphetamine, and atomoxetine: analysis of spontaneous reports submitted to the food and drug administration adverse event reporting system by Wei Wei, Wei Wei, Wei Wei, Li Chen, Li Chen, Hui Zhou, Hui Zhou, Jinfeng Liu, Yue Zhang, Shiyu Feng, Shiyu Feng, Shiyu Feng, Yingtao Bai, Yanen Leng, En Chang, Liang Huang, Liang Huang

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Adverse events associated with molnupiravir: a real-world disproportionality analysis in food and drug administration adverse event reporting system by Yankun Liang, Yankun Liang, Lin Ma, Yuting Wang, Jingping Zheng, Ling Su, Jun Lyu, Jun Lyu

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Innovation Process and Industrial System of US Food and Drug Administration-Approved Software as a Medical Device: Review and Content Analysis by Jiakan Yu, Jiajie Zhang, Shintaro Sengoku

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Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations by Yassine Kamal Lyauk, Daniël Martijn Jonker, Trine Meldgaard Lund

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Sociodemographic Characteristics of Women Able to Obtain Medication Abortion Before and After Ohio's Law Requiring Use of the Food and Drug Administration Protocol by Ushma D. Upadhyay, Nicole E. Johns, Alice F. Cartwright, Tanya E. Franklin

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A comparison of the Food and Drug Administration's and Health Canada's regulatory decisions about failed confirmatory trials for oncology drugs: an observational study by Joel Lexchin

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